Kornimate/medical-research-clean huggingface dataset:
a 10-week efficacy and safety study of gabitril in the treatment of adults with generalized anxiety disorder

Conditions: Anxiety Disorder

Summary: the purpose of this study is to evaluate the safety and efficacy of an investigational anti-anxiety medication relative to placebo in patients with generalized anxiety disorder (gad).


Eligibility criteria:
inclusion criteria: * subjects 18 to 64 years of age (inclusive) will be eligible to participate if they satisfy the dsm-iv-tr criteria for gad, as well as meeting the required screening and baseline visit scores for a series of psychiatric evaluations (i.e., ham-a, hads, madrs and cgi-s). exclusion criteria: * have been previously unresponsive to two or more adequate courses of pharmacological treatment for gad * have been diagnosed with any other psychiatric axis i disorder (except gad) as a principal diagnosis within the past six months * have been diagnosed with any eating disorder within the past six months * have any history of ocd, psychotic disorder, bipolar disorder or antisocial personality disorder * have any history of alcohol or substance abuse within 3 months of screening * have any history of seizures, including febrile seizures * have any history of head trauma associated with loss of consciousness within the past 15 years
efficacy of hydroxycinnamates and beta-glucans as a dietary tool against obesity (obhealth)

Conditions: Overweight/Obesity; Insulin Resistance

Summary: the study aimed at assessing the effect of a decaffeinated green coffee extract, rich in hydroxycinnamates, oat beta-glucans or the combination of both bioactive compounds on overweight/obese subjects with hyperglycemia.

in a randomized, crossover, blind, three-arm study, volunteers consumed twice a day a nutraceutical providing 5 g/d beta-glucan (bg), 600 mg/d green coffee polyphenols (gc) or a combination of both (5 g/d bg + 600 mg/d gc). each intervention stage lasted 8 weeks and was followed by a 4-week wash-out. blood, urine and fecal samples were obtained at the beginning and end of each intervention stage. blood pressure, oral glucose tolerance test (ogtt) and body composition (body weight, anthropometry, bioimpedance) were measured at each control visit. physical activity was controlled by accelerometry (1 week during each intervention stage). energy expenditure was measured by calorimetry. food intake was monitored by 3-d food records. satiety was determined by subjective (vas) and objective (weighting consumed food) records after consuming the nutraceutical during each intervention stage. in a subset of volunteers (9), a pharmacokinetic study was performed to assess bioavailability and metabolism of polyphenols at the beginning and end of each intervention (gc and gc+bg only). in these volunteers, blood was taken at different times during 24 h; urine samples were also collected at different intervals during 24 h, and feces were obtained at 0 and 24 h approximately after consuming the nutraceuticals containing gc. a targeted metabolomic analysis was carried out in these samples. in these volunteers, incretins and hormones were also determined in blood samples.

Eligibility criteria:
inclusion criteria: * men and women, with bmi between 25-35 kg/m2 * fasting blood glucose between 6,11-6,94 mmol/l (110-125 mg/dl) and/or * blood glucose between 7,77-11,04 mmol/l (140-199 mg/dl) 2 h after an oral glucose overload exclusion criteria: * having other chronic pathologies different from overweight/obesity and prediabetes. * on prescription drugs, hormones or dietary supplements (e.g. dietary fibre, pollen, vitamin complexes, etc.) * vegetarian * smoking * known hypersensibility/allergy to any of the tests products * pregnant women * on dietary regimen or physical training to lose weight

Keywords: obesity non-communicable diseases polyphenols soluble dietary fiber nutraceutical
massive transfusion in trauma patient registry

Conditions: Trauma

Summary: the early use of blood products as a part of massive transfusion protocol (mtp) during trauma resuscitation has been increasingly supported by providers and backed by the literature. however, the incidence of hypocalcemia during mtp has also been recorded and continues to be studied as an exacerbating factor in coagulopathy during trauma.

although initially it was thought that the coagulopathy was due to the trauma itself, studies suggest that it is worsened by the transfusion of blood as this is associated with increased hypocalcemia. the level of hypocalcemia is said to correlate with the amount of blood products transfused, but the number of units needed to produce a particular degree of hypocalcemia remains to be defined. a standardized value for hypocalcemia due to mtp has yet to be established. establishing this value would be helpful in determining what level actually affects the rate of mortality. some studies suggest intravenous calcium supplement should be considered during massive transfusion while others state this does not make a difference. this data repository will serve as a means to aggregate and analyze best practices as relative to mtp in the trauma patient, with specific interest in component best practices, whole blood protocols, and electrolyte/metabolite replacement.

Eligibility criteria:
inclusion criteria: * • ≥18 years old * included in the methodist dallas medical center(mdmc) trauma registry * flagged for mtp activation and/or \>1unit(u) blood product recorded in the first 24 hours exclusion criteria: * • \<18 years old
evaluating true pcr-negative rate of frontline dasatinib in early chronic phase cml for therapeutic harmonization

Conditions: Chronic Myelocytic Leukemia

Summary: this study is designed to confirm the efficacy of dasatinib 100mg once daily in producing a complete molecular response and to prove a possibility of "operational cure" in cmr patients.

this study also examines kinetics of complete molecular responses using new highly sensitive pcr based technology, digital pcr, which is reported to have a sensitivity down to 6 log reduction.

Eligibility criteria:
inclusion criteria: * patients must have ph+ cml in cp * newly diagnosed chronic phase cml, except hydroxyurea, anagrelide and within 7 days imatinib treatment * subjects must be enrolled in this study within approximately 3 months (90 days) after the date of first being diagnosed with cml. subjects are allowed to have clonal chromosomal abnormalities in addition to the philadelphia chromosome and remain eligible * 0-2 ecog performance status (ps) score * adequate hepatic function test * adequate renal function test * adequate other organ functions * women of childbearing potential (wocbp) must be using an adequate method of contraception to avoid pregnancy * wocbp must have a negative serum or urine pregnancy test (minimum sensitivity 25 iu/l or equivalent units of hcg) within 72 hours prior to the start of investigational product. * subjects agree to sign informed consent exclusion criteria: * wocbp who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one month (4 weeks) before and for at least 1 month (4 weeks) after the last dose of study medication. * wocbp using a prohibited contraceptive method (not applicable for this study). * women who are pregnant or breastfeeding. * women with a positive pregnancy test at enrollment or prior to administration of study medication. * men whose sexual partners are wocbp, who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one month (4 weeks) after completion of study medication. * a serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy. * known pleural effusion at baseline. * uncontrolled or significant cardiovascular disease * history of significant bleeding disorder unrelated to cml * prior chemotherapy for peripheral stem cell mobilization. (prior collection of un-mobilized peripheral blood stem cells is permitted). * prior or concurrent malignancy * evidence of digestive dysfunction that would prevent administration of study therapy by mouth * uncontrolled diabetes
clinical trial for the investigational drug (pb-201) in subjects with type 2 diabetes mellitus

Conditions: Type2 Diabetes Mellitus

Summary: this crossover study investigates the safety, tolerability, pharmacokinetics (pk) ,pharmacodynamics (pd) effect of three dose levels of pb-201,and characterizes the pk profile of a prominent des-methyl metabolite of pb-201(wi-0800), following dosing of three dose levels of pb-201 in drug-naive chinese adult subjects with type 2 diabetes mellitus (t2dm) as monotherapy. there were 7 days separating 4 treatment periods and at least 7-day washout (but not exceeding 14 days) between dosing in 4 periods with 3 dose levels of pb-201 and placebo. three dose levels of pb-201 are: split dose regimen of 50 mg 30 minutes before morning meal plus 50 mg 30 minutes before lunch at approximately 3.5 hours after morning dose, and split dose regimen of 100 mg 30 minutes before morning meal plus 100 mg 30 minutes before lunch at approximately 3.5 hours after morning dose, and split dose regimen of 150 mg 30 minutes before morning meal plus 100 mg 30 minutes before lunch at approximately 3.5 hours after morning dose.


Eligibility criteria:
inclusion criteria: 1. glycosylated hemoglobin (hba1c) 7.5%-11% at screening, and 7.0%-10.0% pre-randomization 2. fpg 7.0 mmol/l-11.0mmol/l at screening and pre-randomization 3. body mass index (bmi) 18.5 and-35.0 kg/m2 at screening 4. antidiabetics-naive within 2 months before screening exclusion criteria: 1. diagnosis of type 1 diabetes mellitus or secondary forms of diabetes 2. history of febrile illness within 5 days prior to dosing 3. medical history of myocardial infarction, angina/unstable angina, coronary revascularization, stroke or transient ischemic attack 4. any medical history or current clinical evidence of congestive heart failure, new york heart association (nyha) functional classification, classes ii-iv 5. episode(s) of hypoglycemia adverse events (hae) of 'severe' intensity prior to screening; either: 1. \>1 in the previous 3 months; or 2. \>2 in the previous 6 months

Keywords: glucokinase activator(gka) hypoglycemia
intralesional bevacizumab for treating aids-associated kaposi´s sarcoma of the larynx, pharynx and oral cavity

Conditions: Kaposi´s Sarcoma

Summary: kaposi sarcoma remains the most common malignancy among persons with hiv. lesions localized to the airway may cause bleeding, pain and dyspnea. new therapeutic approaches for local disease are needed. the purpose of this study is to compare the effectiveness of intralesional bevacizumab + haart vs haart alone in treating localized kaposi´s sarcoma of the airway in patients with aids.

once disseminated disease is excluded, histologically confirmed hiv-positive patients with localized kaposi's sarcoma of the airway will be randomized to receive haart only or haart + intralesional bevacizumab. the primary outcome will be the size of lesions according to recist criteria. patients in the haart + bevacizumab arm will undergo series of 3 bevacizumab injections of 5 mg/cm3. follow-up will be carried out through scheduled meetings for office setting examination every week for the first 8 weeks, then every 15 days for two months and finally every month for eight months. size of the lesions will be assessed by an independent observer and adverse events will be recorded.

Eligibility criteria:
inclusion criteria: * hiv infected * ks of the oral cavity, pharynx and larynx, histopathologically confirmed * hiv treatment-naïve exclusion criteria: * airway obstructive lesions * actively bleeding lesions * tumor-associated oedema or ulceration * gastrointestinal ks * ks in other nonnodal viscera

Keywords: kaposi sarcoma hiv bevacizumab
balloon dilation of the eustachian tube in children

Conditions: Glue Ear; Tube Disorders Eustachian

Summary: otitis media with effusion (ome) is very common in children and characterized by fluid in the middle ear without signs or symptoms of acute ear infection. treatment options are tympanostomy tubes and/or adenoidectomy. however ome often reoccurs after these procedures. goal of this study will be to evaluate the balloon eustachian tuboplasty (bet) in children as an additional treatment option and to assess long-term effects of bet. beside the standard procedure, children (4 to 10 years of age), with equal pathology on both ears, will be assigned for bet on side.

introduction: otitis media with effusion (ome, "glue ear") is very common in children and characterized by fluid in the middle ear without signs or symptoms of acute ear infection. fluid in the middle ear causes conducting hearing loss. ome has a large impact on health care costs and recurrent or persistent ome can effect the proper development of children. frequently ome resolves itself, therefore guidelines strongly recommend watchful waiting for 3 months after which treatment options are tympanostomy tubes and/or adenoidectomy. however ome often reoccurs after these procedures. furthermore there are various short and longterm side-effects of tympanostomy tubes.in balloon eustachian tuboplasty (bet) a ballon catheter is used to dilate the cartilage part of the eustachian tube and is inserted through the nose to reach the opening of the tube, located in the nasopharynx. bet has recently been applied in children for therapy-resistant recurrent ome and inflammatory ear diseases with promising results. risk and complications rates are very low. methods: goal of this study will be the evaluation of balloon eustachian tuboplasty (bet) in children as a primary treatment of ome. children between the ages of 4 and 10 years with ome and tympanometry type b on both ears, will prospectively be recruited and assigned for adenoidectomy and myringotomy. parents then will be asked for participation in this trial and fully informed about purpose, technique and possible side effects. if consent is given, adenoidectomy, in case of large adenoids, and myringotomy will be performed on both sides. if necessary (very thick fluid) tympanostomy tubes are placed. one eustachian tube of each patient is randomly assigned for bet.

Eligibility criteria:
inclusion criteria: * ome on both sides measured by flat tympanometry exclusion criteria: * patients with cleft lip and/or palate and other severe craniofacial abnormalities
open-label creatine study for female meth users

Conditions: Depression; Dual Diagnosis; Substance Use

Summary: study purposes and objectives: the objectives should be stated in such a way that the reader can determine the appropriateness of the study design. if appropriate, state the specific hypotheses being tested and/or study aims. use lay language. methamphetamine use is of great concern in the state of utah because it's the primary drug of threat in the state, and is the primary drug of choice among females between the ages of 18 and 24. the primary hypothesis of the study is that eight weeks of oral creatine supplementation will result in improvements in depression rating scores in female ma users. secondary hypotheses include the following: 1) creatine supplementation will result in a decrease in the number of positive ma screens; 2) naa and cr concentrations will increase after eight weeks of oral creatine supplementation; and 3) pcr/β-ntp levels in the frontal lobe using 31p mrs will increase after eight weeks of creatine monohydrate oral supplementation.


Eligibility criteria:
inclusion criteria: 1. must be female 2. must be between the ages of 13 and 55 years 3. methamphetamine must be primary drug of choice 4. must have used methamphetamine within the last 6 months 5. for participants \> 18 years of age, must have a hamilton depression rating scale (hdrs or ham-d) score of \> 17 6. for participants \ 40 7. must be able to give informed consent exclusion criteria: 1. significant current or past medical conditions, such as cardiovascular, renal or endocrine disorders 2. dsm-iv diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder 3. known pregnancy or positive urine hcg test 4. current serious homicidal or suicidal risk 5. young mania rating scale (ymrs) score \> 7 6. inability to comply with the protocol 7. contraindication to an mr scan 8. positive hiv test 9. known sensitivity to creatine monohydrate inclusion criteria for healthy comparison group: 1. must be female 2. must be between the ages of 13 and 55 years 3. must be able to give informed consent exclusion criteria for healthy comparison group: 1. significant current medical illness 2. dsm-iv disorder identified by the scid (to include bipolar i, bipolar ii, bipolar nos, major depressive disorder, dysthymia disorder, depressive disorder nos, primary psychotic symptoms, substance use disorders, and anxiety disorders) 3. known pregnancy or positive urine hcg test 4. contraindication to an mr scan 5. inability to comply with the protocol 6. positive urine drug screen (unless it is positive for a low dose prescription opiate that is taken as prescribed)
the usefulness of caimr in patients with stemi

Conditions: CaIMR; Prognosis; ST-segment Elevation Myocardial Infarction

Summary: the coronary artery system is composed of three different types of blood vessels, namely epicardial arteries, arterioles and capillaries. compared with epicardial arteries, arterioles and capillaries are lower than the resolution of current angiography systems, so angiography cannot be used for visualization. existing studies have shown that coronary microcirculation plays an extremely important role in maintaining full myocardial perfusion. coronary microvascular disorders can lead to myocardial hypoperfusion and ischemia, and are related to the poor prognosis of patients with coronary heart disease. at present, there is no technology that can directly detect the state of the coronary microcirculation in the human body, but the coronary microcirculation function can be indirectly assessed through two invasive and non-invasive methods. among them, the index of microcirculation resistance (imr) is widely used to evaluate coronary microcirculation function \[3\]. however, in the case of epicardial stenosis, accurate determination of imr requires knowledge of coronary artery contraction pressure (pw). however, measuring imr is an invasive examination technique, and measuring imr requires high technical requirements for the operator. therefore, the caimr value obtained by ai technology can well overcome this limitation, and the existing data show that the caimr value has a good correlation with the imr value. however, caimr has a clinical prognosis for patients with acute st-segment elevation myocardial infarction. the predictive value of caimr has not yet been explored. this project aims to evaluate the application value of caimr in predicting the occurrence of adverse cardiovascular events in patients with acute st-segment elevation myocardial infarction after percutaneous coronary intervention.


Eligibility criteria:
inclusion criteria: * patients who are clinically diagnosed with acute st-segment elevation myocardial infarction and are planned to undergo pci; * volunteer to participate and sign the informed consent exclusion criteria: * coronary angiography suggests that it is not suitable for pci; * have performed cabg surgery in the past; * lesion of left or right coronary ostium; * the target vessel is an infarct-related artery (old or acute myocardial infarction recovery period); * the immediate effect of target vessel pci is not ideal (such as: final timi blood flow \ 1.5 mm, distal embolism or thrombus shown by angiography); * severe systemic infection; * patients with malignant wasting disease whose estimated survival time is less than 1 year.
lateral cord stimulation as a new treatment for refractory spastic cerebral palsy

Conditions: Cerebral Palsy; Spasticity

Summary: the aim of our work is to investigate whether electrical lateral cord stimulation (lcs) causes an inhibitory and modulatory action by indirect cerebellar activation, so releasing spasticity and the spastic syndrome in selected cases of patients with cerebral palsy

project lateral cord stimulation was thought by the author to be employed in patients with spastic cerebral palsy with the aim to improve tonus, motor function and speech. nevertheless, as it has been demonstrated as acting on the basic phenomena related with spasticity, it's to say the propagated spinal responses, its use could be extended to other forms of spastic disease, like spastic limbs post stroke, brain congenital malformations producing spasticity and motor disorders as the main signs, post anoxic encephalopathy, etc. in this preliminary clinical trial, classed as phase 3, our sample must be very limited to assure stable conditions for statistical significance, hence our group is going to be circumscribed to certain conditions and pathology. in the future, as long the method could spread its use, the extension on indications in other pathological conditions is advisable thus, its possibilities of marketing could be enlarged with its use in a broader spectrum of spastic patients. calculated risks are similar to those related with the ancient surgical technique called "scoville"technique, currently employed time ago for cervical discectomy (6) investigational plan the purpose of this clinical trial is to release spasticity and by this means improve the condition of patients with spastic cerebral palsy by extradural lateral cord electrical stimulation, by using currently employed electrodes and neurostimulators those devices are already fda approved and currently used for dorsal column stimulation with the objective to treat chronic pain and spasticity (spasmodic torticollis).

Eligibility criteria:
inclusion criteria: * aged sixteen or older * spastic cerebral palsy with stable condition * motor disability unilateral or predominantly unilateral. * troubles of speech clinically evident. * normal or slightly sub-normal i.q * no psychiatric disorders. exclusion criteria: * severe cardiac or respiratory troubles * fixed abnormal postures (except if previously corrected by orthopedic surgery) * chronic recurrent bronchial or pulmonary infections * chronic recurrent urinary infections * severe osteoporosis on affected limbs * chronic skin ulcerations.

Keywords: dysarthria electrical stimulation lateral cord stimulation spasticity treatment
management of imatinib-associated severe skin rash in patients with gastrointestinal stromal tumor

Conditions: Gastrointestinal Stromal Tumor(GIST)

Summary: to achieve optimal clinical outcomes with imatinib in gist patients, it is crucial to maintain standard imatinib dose. skin rash is a relatively common and sometimes severe adverse event of imatinib in gist patients and may affect imatinib compliance. our previous retrospective study suggested that severe skin rash induced by imatinib can be managed by systemic steroid without imatinib dose interruption or reduction. this phase ii study was conducted to evaluate the efficacy and safety of systemic steroid in gist patients with imatinib-associated severe skin rash.


Eligibility criteria:
inclusion criteria: * age 18 years or older, at the time of acquisition of informed consent * histologically confirmed metastatic and/or advanced (unresectable or recurrent) gist with cd117(+), dog-1(+), or mutation in kit or pdgfrα gene * patients with metastatic and/or advanced (unresectable or recurrent) gists, receiving imatinib as adjuvant or neo adjuvant, palliative chemotherapy for pre-or post- operations * imatinib-associated severe skin rash which was defined as grade 3 skin rash or grade 2 skin rash with pruritus over grade 2

Keywords: gastrointestinal stromal tumor skin rash imatinib